Effectiveness of Chinese Herbal Therapy for Asthma

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00712296
First received: July 7, 2008
Last updated: December 29, 2009
Last verified: December 2009
  Purpose

The purpose of this study is to determine the efficacy of an anti-asthma herbal medicine intervention (ASHMI) in adult asthmatics


Condition Intervention Phase
Asthma
Drug: ASHMI
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Center for Chinese Herbal Therapy for Asthma. Project #2-Clinical Effect of a Chinese Herbal Therapy in Human Asthma-Phase II

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Number of patients whose asthma medication regimen (Inhaled corticosteroids) can be stepped down at least two levels [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary function tests [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Asthma symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Asthma-related quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Airway hyperreactivity [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Acute asthma-related resource utilization [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Immunologic markers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ASHMI 6 capsules twice a day
Drug: ASHMI
6 capsules orally twice a day
Experimental: 2
ASHMI 2 capsules twice a day plus placebo 4 capsules twice a day
Drug: ASHMI
2 capsules orally twice a day
Placebo Comparator: 3
Placebo 6 capsules twice a day
Drug: Placebo
Placebo 6 capsules twice a day

Detailed Description:

Asthma is a major public health problem worldwide, particularly in westernized societies and has continued to increase in prevalence over the past two decades. Inhaled corticosteroids have become the first-line treatment for persistent asthma even though side effects have been reported. New asthma medications, including leukotriene inhibitors and anti-IgE, have shown limited benefits. Patients have increasingly turned to complementary and alternative medicine (CAM) for treatment of their asthma, despite the uncertainty of its benefits due a lack of well-controlled scientific studies.

We have developed a Chinese herbal formula composed of 3 herbs called ASHMI. It has been previously shown in murine studies that ASHMI (a formula containing Ling Zhi, Ku Shen and Gan Cao) has therapeutic effects on the major pathogenic mechanisms of asthma-airway hyperreactivity, pulmonary inflammation, and airway remodeling, as well as a down-regulating of TH2 response. A subsequent study in 91 asthmatic patients in Weifang, China found ASHMI to be a safe and effective alternative to prednisone for treating asthma and exhibited a beneficial effect on TH1 and TH2 balance. Additionally, a Phase I study conducted in the United States showed good tolerability to ASHMI. Based on these preliminary studies, we hypothesize that ASHMI will be a safe medication in patients with asthma.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects ages 18 through 55 and otherwise in good health as determined by medical history and physical examination
  • History of asthma documented by a physician for at least 6 months
  • Females of childbearing potential must be sexually inactive or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study
  • The subject agrees to participate in the study
  • Subjects must have one of the following:
  • one asthma-related unscheduled visit to an Emergency Department or clinic in the past 12 months
  • One overnight hospitalization in the past 12 months
  • Disturbed sleep more than twice in the past month
  • Asthma symptoms ≥8 times in the past month
  • use of a β2-agonist ≥8 times in the past month
  • two short courses (3-7 days) of oral corticosteroids in the last 12 months
  • FEV1 <80% predicted AND Use of inhaled corticosteroid (ICS) for at least 1 month prior to enrollment

Exclusion Criteria:

  • Acute illness (such as cold, flu, etc.) within two weeks before the screening visit
  • Any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, including hepatitis virus infection
  • History of chronic obstructive lung disease, emphysema, or other chronic respiratory condition
  • Abnormal hepatic function (ALT/AST and bilirubin >1.25 x upper limit of normal)
  • Abnormal bone marrow function (WBC <4 x 103/mm3; platelets <100 x 103/mm3; Hgb <11 g/dl)
  • Abnormal renal function (BUN and creatinine >1.25 x upper limit of normal)
  • Clinically significant abnormal electrocardiogram
  • FEV1 <50% predicted
  • Participation in another experimental therapy study within 30 days of this study
  • History of alcohol or drug abuse
  • Pregnant or lactating female subjects. Females of childbearing potential will need a negative serum pregnancy test at screening to be considered for this study
  • Subjects receiving treatment with Omalizumab or immunotherapy for asthma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712296

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Juan P Wisnivesky, MD, MPH Mount Sinai School of Medicine
  More Information

Publications:
Responsible Party: Xiu-Min Li, MD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00712296     History of Changes
Other Study ID Numbers: P01 AT002647-2, P01AT002647-02, 5 P01 AT 002647-02
Study First Received: July 7, 2008
Last Updated: December 29, 2009
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Mount Sinai School of Medicine:
Asthma
alternative medicine
complementary medicine
herbal therapy

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 14, 2014